CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
OMK2 group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04009980
NCT04009980N/ACompleted

Long-term Morphological and Functional Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus: Pilot Study

Fondazione G.B. Bietti, IRCCS·interventional·Posted Jul 8, 2019·Updated Jul 8, 2019

In Brief

A clinical study evaluating OMK2 group and Placebo group for Diabetic Retinopathy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Citicoline (cytidine-5'-diphosphocholine) is an essential precursor in the synthesis of phosphatidylcholine, a component of cell membranes. Several experimental in vitro and in vivo studies have suggested that citicoline plays a neuroprotective role. A recent clinical study has shown that treatment with topical citicoline induces, after 60 days of therapy, a significant improvement in the ganglion cell function .In addition topical citicoline has been demonstrated in vivo a neuroprotective effect in preventing diabetic retinopathy . The Investigators want to evaluate if citicoline may reduce the progression of retinal damage in patients with mild diabetic retinopathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 8, 2019
Enrollment StartSep 23, 2015
Primary CompletionOct 1, 2018
Study CompletionJun 7, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.0 years ago

Interventions

OMK2 groupother

topical administration of OMk2 ophthalmic solution for 36 months three times/day

Placebo groupother

topical administration of ophthalmic placebo solution for 36 months three times/day